This is the 35 USC 371 National Stage of International application PCT/FR97/01569 filed on Sep. 5, 1997, which designated the United States of America.
The invention concerns an intra-buccal-pharyngeal device for treating ronchopathy.
The invention is more particularly aimed at eliminating snoring and preventing sleep apnoea affecting some patients when sleeping.
FIG. 6 of the accompanying drawings shows the relevant anatomy and is used to explain the mechanisms of snoring.
Snoring is a noise produced when breathing in, or predominantly when breathing in, by vibration of soft pharyngeal tissue.
The mechanism of snoring is not yet fully explained. Snoring could be the result of the interaction of a number of anomalies: local anatomical factors, abnormally collapsible pharyngeal walls, muscle tone problems and the like.
Many anomalies can constrict the upper respiratory tracts: nasal obstruction by deflection of the septum 20, macroglossia or hypertrophy of the tonsils 23, retro- or micro-gnathism.
In xe2x80x9cbenignxe2x80x9d snoring the pharynx shrinks significantly. This reduction in the pharyngeal passage is due to an excessively long soft palate 15 and uvula 16, descending behind the base 14 of the tongue 13. Oscillation of these structures generates an audible vibration, snoring.
In heavy snorers, in addition to the noise, the increased pharyngeal resistance limits the flow on breathing in at various levels, in particular in the region of the soft palate 15 and the base 14 of the tongue 13 which are pressed against the posterior pharyngeal wall 18. Dorsal decubitus encourages snoring, perhaps because the tongue 13 drops back, but above all because the base of the tongue 14 presses against the posterior pharyngeal wall 18.
Snoring causes many problems. Apart from the nuisance to others, snoring causes impoverished sleep and reduces oxygenation of the blood to a greater or lesser extent, which can have harmful consequences for all of the organism. It appears that heavy snorers, more often than light snorers, are affected by arterial hypertension and cardiac ischaemic problems of the angina or myocardial infarctus type. They would also seem to have a predisposition to cerebral ischaemia.
Sleep apnoea syndrome (SAS) is a more severe form of snoring. It consists in heavy snoring associated with real apnoea, of greater or longer duration, but possibly lasting up to two minutes and repeating throughout the night, through total obstruction of the pharyngeal airway.
These interruptions of respiration cause successive awakenings (through the operation of the safeguard system) so that the pharyngeal muscles contract and allow air to pass into the lungs.
During the daytime the main symptom is drowsiness. It varies in severity, from the simple feeling of chronic fatigue to unintentional falling asleep during activity.
Various means have been invented and tried in order to reduce or even eliminate snoring: special pilows (international patent application WO-91/11157), xe2x80x9cgadgetsxe2x80x9d preventing sleeping on the back, various medications, electronic systems for partially awakening the sleeper, intra-buccal devices for holding the jaws apart (patent application EP0599445 and international patent application WO-94/28832) or for pressing back the tongue (international patent applications WO-92/09249 and WO-96/25193), but in all cases without significant results.
More recently, and because of our better knowledge of mechanisms causing sounds during snoring, surgery of the pharynx has represented a notable advance in the treatment of these problems. In the case of SAS, respirators have been developed to insufflate air at a positive pressure (C.P.A.P.: xe2x80x9cContinuous Positive Air Pressurexe2x80x9d) to prevent apnoea.
All prior art methods and devices are either ineffective or effective but costly and/or bulky and at least difficult for patients to use on themselves outside the hospital environment.
U.S. Pat. No. 3,057,347 describes a device for resuscitating patients suffering from respiratory arrest, for example after electrocution or drowning.
The device has a canula with a curved proximal part and a straight distal part, intended to be inserted as far as the base of the tongue and through the buccal cavity, respectively, projecting out of the buccal cavity so that a rescuer can insufflate air. The distal part has a support disc radially around it and which rests on the lips of the patient to position the assembly correctly. A filter in the distal part of the canula prevents moisture insufflated with the air breathed out by the rescuer from reaching the respiratory tracts of the patient. The canula is made from a semi-rigid elastic material so that it can adapt to the particular anatomical conformation of each patient. Application of the above device is exclusively reserved to resuscitation of patients and the device is intended in particular to create a non-obstructed passage between the mouth of the rescuer and the respiratory tracts downstream of the base of the tongue (larynx and trachea). Because the patient is unconscious, the canula must have sufficient rigidity to be inserted, possibly forcibly inserted, as the pharyngeal muscles may have become tetanized because of the trauma.
The aim of the present invention is to propose a simple and effective device for treating ronchopathy and sleep apnoea, which avoids all the drawbacks of previously used devices and methods, surgical or otherwise, the device being particularly convenient to use and easily fitted by a patient suffering from ronchopathy and/or sleep apnoea.
The invention therefore consists in a device for treating ronchopathy and sleep apnoea adapted to be placed in the oro-pharynx and in the pre-buccal region, characterized in that it comprises in combination:
an anatomical shape curved tube having a length such that in situ its proximal end reaches at least the base of the tongue and its distal end projects out of the buccal cavity, and
reinforcing means near said distal end and adapted to reinforce said tube in the area of the teeth and the lips to prevent crushing said tube,
so that, placed in the oro-pharynx of a patient while sleeping, the airflow produced by the patient can pass freely and without obstacle between the outside and the area downstream of the base of the tongue, without blockage and without causing vibration of surrounding soft tissue, in particular the soft palate, the base of the tongue and the pharyngeal wall.